Create an Inspection Readiness Gap Analysis

Create an Inspection Readiness Gap Analysis - Webinar CD/Transcript

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Create an Inspection Readiness Gap Analysis: How to Avoid the FDA’s Top 29 483 Citations

Who's that sitting in your lobby?

Watch out … it may be your regional FDA inspector, just dropping by for an unannounced inspection of your facilities.

If this happens to you — will you be ready?

If this fictional scenario sounds like hype to you, then listen to what just happened to the folks at device and drug maker Hospira.

Late last year — with the holiday season approaching — the FDA broadsided a major pharma company with a series of warning letters at their facilities in Colorado, North Carolina, Kansas, Illinois and Costa Rica.

Why weren't the facilities better prepared? After all, many of the problems uncovered during their inspections are common within the drug and device industries.

Don't take the chance of being next in line for an unannounced inspection.
Order the webinar CD and transcript set
Create an Inspection Readiness Gap Analysis TODAY.

This set features a list of the 29 top problems that repeatedly show up in 483s and warning letters.

Dr. David Lim, an accomplished former FDA official with CDRH and a pharma executive, pulled together this 29-point hot list by combing through data from FDA inspections over the last seven years. Step-by-step, he reveals why — and how — the FDA focuses on all 29 of them

It's the best possible way to begin preparing your own inspection readiness gap analysis. In 90 minutes, you'll gain an understanding of where your facility's compliance weaknesses might be, and you'll also learn:

  • Why the 29 top problems continually show up in 483s — and how to best deal with these common citations
  • What resources FDA investigators use to guide their inspections: IOMs, Inspection Guides, FMD and CPGM
  • How the FDA manages inspection logistics: what regional office will conduct your investigation, and how your investigator will be picked
  • Definitions of inspection types, categories and classifications
  • What  the difference is in FDA Forms 482, 483 and EIRs
  • What (and how) to prepare for and respond to an FDA inspection
  • Tips and best practices for communications before, during and after FDA inspections
  • How to determine what the close out meeting should accomplish, and what you should do if there are lingering disagreements during the meeting
  • How best to respond to a 483, and who should reply to it: in-house staff or an outside counsel/consultant?
  • How to reach continuous quality and inspectional readiness, plus best practices for achieving compliance and staying compliant year round

At a time when your compliance resources are probably scarce, Dr. Lim's FDA inspection webinar CD and transcript set is an excellent, affordable way to begin preparing your inspection readiness gap analysis.

  • Manufacturing directors
  • Quality assurance
  • Regulatory affairs
  • Compliance
  • Legal

Dr. David Lim, a former FDA employee, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia. He discovered a novel growth factor and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke University Medical Center (Duke), California Institute of Technology (Caltech), University of California at Berkeley (UC-Berkeley), US National Laboratories, Intrexon, Terumo, US FDA/CDRH, and EraGen Biosciences (Luminex Company).

In 2009, he served as a panel member during the FDA’s transparency public meeting. Prior to forming the Regulatory Doctor consultancy, Dr. Lim was the Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals.